摘要
Ipratropium bromide （IB） is an effective treatment for reversible bronchospasm associated with COPD. Cipla Ltd. hasdeveloped a formulation of lpratropium bromide pMDI （Test IB） which is designed to be equivalent to the originator product Atrovent HFA pMDI （Reference IB） as a cost effective alternative for the treatment of COPD. The objective of the study was to establishnon-inferiority of the Test 1B to Reference 1B in patients with stable COPD. In this multicenter, randomized, double-blind, doubledummy, parallel group study, patients aged 〉 40 years were randomized to receive 2 puffs three times daily （TID） of either the Test IBor Reference IB for 12 weeks. The primary endpoint was the change from pre dose to post dose FEVj at 90 min at the end of 12 weeks.Secondary endpoints included FVC, symptom score, rescue medication use and St. George＇s Respiratory Questionnaire （SGRQ）.Safety and tolerability included evaluation of adverse events （AEs）, vital signs assessments, physical examination and any change inconcomitant medications. A total of 395 patients were randomized to either the Test IB （n = 199） or the Reference IB （n = 196）; themajority of patients were male with a mean pre-bronchodilator FEV1 （% predicted） of 60%. The per protocol set comprised of 258patients （n = 129 in each treatment group）. The mean treatment difference between the Test IB and Reference 1B for the primaryendpoint （mean change in FEV1 from pre-dose to 90 rain post dose at 12 weeks） was -0.003 L and the lower limit of the 95% confidenceinterval （CI） for the difference between the two products was -0.041 Lwhich is greater than the predefined non inferiority limit of-0.100 L. No significant difference was seen between the Test IB and Reference IB for any secondary efficacy variables. The AEprofile was also comparable between the two treatments. The results indicate that the Test 1B （Ipratropium Bromide HFA pMD1, CiplaLtd.） is non inferior to the Reference lB.
